ID

36685

Description

Study of the Efficacy of SBRT on Unresectable Peripheral Primary Tumor; ODM derived from: https://clinicaltrials.gov/show/NCT02400424

Link

https://clinicaltrials.gov/show/NCT02400424

Keywords

Versions (1)
  1. 6/1/19 6/1/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 1, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-small-cell Lung Carcinoma NCT02400424

English

Eligibility Non-small-cell Lung Carcinoma NCT02400424

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years ≤ age ≤ 75 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ps ecog 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
histologically proven nsclc
Description

Non-Small Cell Lung Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0007131
unresectable stage iii: t1 or t2 or t3 ≤ 5 cm and n2 or n3 (only contralateral mediastinum or homolateral supraclavicular).
Description

Tumor unresectable TNM clinical staging Tumor size | TNM clinical staging Mediastinum Contralateral | TNM clinical staging Supraclavicular region Ipsilateral

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1519810
UMLS CUI [1,3]
C3258246
UMLS CUI [1,4]
C0475440
UMLS CUI [2,1]
C3258246
UMLS CUI [2,2]
C0025066
UMLS CUI [2,3]
C0441988
UMLS CUI [3,1]
C3258246
UMLS CUI [3,2]
C0446461
UMLS CUI [3,3]
C0441989
peripheral primary tumor ≥ 1 cm and ≤ 5 cm
Description

Primary tumor peripheral Size

Data type

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0205100
UMLS CUI [1,3]
C0456389
possible concomitant chemoradiotherapy : 1 cure induction and 3 concomitant cycles of chemotherapy with cisplatin and navelbine ® and 3d conformal radiotherapy delivering 66 gy in 33 fractions to the mediastinal lymph node involvement without treating the peripheral tumor.
Description

Chemoradiotherapy | Induction Therapy | Chemotherapy cycle Quantity | Cisplatin | Navelbine | Third Conformal Radiotherapy Number of fractions | Involvement with Mediastinal lymph nodes | Tumor Peripheral Untreated

Data type

boolean

Alias
UMLS CUI [1]
C0436307
UMLS CUI [2]
C0600558
UMLS CUI [3,1]
C1302181
UMLS CUI [3,2]
C1265611
UMLS CUI [4]
C0008838
UMLS CUI [5]
C0131965
UMLS CUI [6,1]
C0600521
UMLS CUI [6,2]
C0205437
UMLS CUI [6,3]
C0454266
UMLS CUI [7,1]
C1314939
UMLS CUI [7,2]
C0588055
UMLS CUI [8,1]
C0027651
UMLS CUI [8,2]
C0205100
UMLS CUI [8,3]
C0332155
adequate biological parameters
Description

Parameters biological

Data type

boolean

Alias
UMLS CUI [1,1]
C0449381
UMLS CUI [1,2]
C0205460
forced expiratory volume (fev) ≥1 liter or ≥ 30% of the theoretical value
Description

FEV1

Data type

boolean

Alias
UMLS CUI [1]
C0849974
patient covered by a health insurance scheme
Description

Health Insurance

Data type

boolean

Alias
UMLS CUI [1]
C0021682
signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
sclc or large cell neuroendocrine carcinoma
Description

Small cell carcinoma of lung | Large cell neuroendocrine carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0149925
UMLS CUI [2]
C1265996
metastatic disease
Description

Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0027627
stage iva
Description

TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C3258246
pregnant or breast-feeding women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Non-small-cell Lung Carcinoma NCT02400424

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18 years ≤ age ≤ 75 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ps ecog 0 or 1
boolean
C1520224 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma
Item
histologically proven nsclc
boolean
C0007131 (UMLS CUI [1])
Tumor unresectable TNM clinical staging Tumor size | TNM clinical staging Mediastinum Contralateral | TNM clinical staging Supraclavicular region Ipsilateral
Item
unresectable stage iii: t1 or t2 or t3 ≤ 5 cm and n2 or n3 (only contralateral mediastinum or homolateral supraclavicular).
boolean
C0027651 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0475440 (UMLS CUI [1,4])
C3258246 (UMLS CUI [2,1])
C0025066 (UMLS CUI [2,2])
C0441988 (UMLS CUI [2,3])
C3258246 (UMLS CUI [3,1])
C0446461 (UMLS CUI [3,2])
C0441989 (UMLS CUI [3,3])
Primary tumor peripheral Size
Item
peripheral primary tumor ≥ 1 cm and ≤ 5 cm
boolean
C0677930 (UMLS CUI [1,1])
C0205100 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
Chemoradiotherapy | Induction Therapy | Chemotherapy cycle Quantity | Cisplatin | Navelbine | Third Conformal Radiotherapy Number of fractions | Involvement with Mediastinal lymph nodes | Tumor Peripheral Untreated
Item
possible concomitant chemoradiotherapy : 1 cure induction and 3 concomitant cycles of chemotherapy with cisplatin and navelbine ® and 3d conformal radiotherapy delivering 66 gy in 33 fractions to the mediastinal lymph node involvement without treating the peripheral tumor.
boolean
C0436307 (UMLS CUI [1])
C0600558 (UMLS CUI [2])
C1302181 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0008838 (UMLS CUI [4])
C0131965 (UMLS CUI [5])
C0600521 (UMLS CUI [6,1])
C0205437 (UMLS CUI [6,2])
C0454266 (UMLS CUI [6,3])
C1314939 (UMLS CUI [7,1])
C0588055 (UMLS CUI [7,2])
C0027651 (UMLS CUI [8,1])
C0205100 (UMLS CUI [8,2])
C0332155 (UMLS CUI [8,3])
Parameters biological
Item
adequate biological parameters
boolean
C0449381 (UMLS CUI [1,1])
C0205460 (UMLS CUI [1,2])
FEV1
Item
forced expiratory volume (fev) ≥1 liter or ≥ 30% of the theoretical value
boolean
C0849974 (UMLS CUI [1])
Health Insurance
Item
patient covered by a health insurance scheme
boolean
C0021682 (UMLS CUI [1])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Small cell carcinoma of lung | Large cell neuroendocrine carcinoma
Item
sclc or large cell neuroendocrine carcinoma
boolean
C0149925 (UMLS CUI [1])
C1265996 (UMLS CUI [2])
Neoplasm Metastasis
Item
metastatic disease
boolean
C0027627 (UMLS CUI [1])
TNM clinical staging
Item
stage iva
boolean
C3258246 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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